Manager Regulatory Affairs - Delhi The Position Ensure that all regulatory updates are shared with local and global teams in timely manner. Ensure that timely and complete regulatory actions are taken regarding assigned product/therapeutic area. Ensure operational RA tasks are executed in timely manner Tasks & Responsibilities Registration of NCE and line extensions for therapeutic area of responsibility Strategies compliant with regulations, Liaise with Health Authority and ensure earliest submission and registration in the country. Follow-up regulatory approvals for the products per registration plan. Liaise with Health Authority regularly and engage in impactful discussion with Senior Regulatory officials. Ensure earliest submission & approvals at the right time to ensure quick implementation of proposed CMC changes as per global timelines. Renewal on time to ensure uninterrupted availability of products in the country. Amendments and updates are approved on time to ensure study is continued in the country and ensure timely notification of notifiable updates. Follow-up on submitted applications at HA. Regulatory Intelligence, ensure all regulatory updates are shared with local and global team in timely manner. Follow the RI procedure of making entry and impact assessment of each relevant update in RINTOOL to maintain RIN database. Requirements Education: Bachelor’s degree in pharmacy or similar medical education. Pharma experience with regulatory focus in a multi-national for at least 8-10 years. Proven track record of Strong Liaising experience in the health authority Solid understanding of D&C Act and Rules. Understanding of working practices at HA. Experience of direct interactions with Regulatory Authorities. Eye for details Analytical skills Communication skills Negotiation skills Position is based in Delhi READY TO APPLY? Click the “Apply On Company website” button. Create an account or sign in and continue to register your profile, upload your resume, and apply in the company site. Experience Level Mid Level
Other Details
It is a Full Time Recruiter / HR / Admin job for candidates with 6+ years of experience.
More about this Regulatory Affairs Manager job
What qualifications and experience are required for this Regulatory Affairs Manager position?
Ans : Candidates should have All Education levels with 8-7 years of experience.
What is the salary and job type for this role?
Ans : Salary details will be shared during the hiring process.
What shift and timings does this job follow?
Ans : This Regulatory Affairs Manager job follows a Day shift.
Do you need to visit the office for this job?
Ans : Yes, candidates need to visit the office and work from the location in Okhla Industrial Area, Delhi.
How many openings are available for this position?
Ans : There is 1 opening available for this position.
Is this job open for all genders?
Ans : Yes, this Regulatory Affairs Manager job is open for both male and female candidates.
Where is this job located?
Ans : This Regulatory Affairs Manager job is located in Okhla Industrial Area, Delhi.
Why should you apply for this Regulatory Affairs Manager job?
Ans : The employer has not disclosed the salary for this role, but it is a Full Time opportunity with 1 opening available.
A Naukri Group company
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Boehringer Ingelheim India Private Limited
Okhla Industrial Area, Delhi
8 - 6+ years Experience in Recruiter / HR / Admin
Full Time
